A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- Adalimumab
- Conditions
- Generalized Pustular Psoriasis (GPP)
- Sponsor
- AbbVie
- Enrollment
- 10
- Primary Endpoint
- Proportion of Participants Achieving Clinical Response at Week 16
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.
Detailed Description
This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of generalized pustular psoriasis
- •Total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the Japan Dermatology Association (JDA) severity index of Generalized Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan
- •Inadequate response to, or intolerance to, or contraindication to the currently approved GPP treatment (excluding infliximab)
- •Infliximab secondary failure, or intolerant to infliximab
Exclusion Criteria
- •Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at Screening
- •Drug-induced GPP
- •Cannot stop ongoing use of prohibited GPP treatments
- •Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in Japan
Arms & Interventions
Participants receiving adalimumab
80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Intervention: Adalimumab
Outcomes
Primary Outcomes
Proportion of Participants Achieving Clinical Response at Week 16
Time Frame: Baseline and Week 16
Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.
Secondary Outcomes
- Number of Participants Achieving Clinical Response Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- Number of Participants Achieving Clinical Remission Over Time(Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in the Total GPP Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Percent Change From Baseline in Total Skin Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in JDA Severity Index of GPP Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Total Skin Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Total Erythema Area Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Total Erythema Area With Pustules Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Total Edema Area Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Body Temperature Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Serum Albumin Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time(Week 8, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time(Baseline, Week 8, Week 16, Week 24, Week 36, Week 52)
- Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time(Baseline, Week 8, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52)
- Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52)
- Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52)